Medical Director Oncology Clinical Development Lead

18 hours ago

North Chicago, Illinois, United States AbbVie Full time
Job Title: Medical Director Oncology Clinical Development

AbbVie is seeking a highly skilled Medical Director to lead our Oncology Clinical Development team. As a key member of our organization, you will be responsible for overseeing the direction, planning, execution, and interpretation of clinical trials or research activities of one or more clinical development programs.

Key Responsibilities:
  • Design and implement clinical development programs in support of an overall Product Development Plan, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, AbbVie's customers, markets, business operations, and emerging issues.
  • Oversee project-related education of investigators, study site personnel, and AbbVie study staff.
  • Have overall responsibility for oversight of clinical studies, monitoring overall study integrity, and review, interpretation, and communication of accumulating data pertaining to safety and efficacy of the molecule.
  • Responsible for assessment and reporting of serious adverse events per corporate policy and regulations for those protocols on which assigned.
  • Design, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions and responses, and other program documents.
  • May oversee the work of Associate Medical and/or Scientific Directors, and of Clinical Scientists working on the same or related programs.
  • Provide in-house clinical expertise for the molecule and disease, coordinating appropriate scientific and medical activities with internal stakeholders as they relate to ongoing clinical projects.
  • May participate in due diligence or other business development activity.
  • Contribute in partnership with Discovery colleagues to design and implementation of translational strategies.
  • May serve on or chair a Clinical Strategy Team (CST), with responsibility for development of a rigorous, cross-functionally-aligned, vetted Clinical Development Plan with full consideration of contingencies and alternative approaches.
  • Act as a clinical interface and actively solicit opinion leader interactions related to the molecule and disease area; partner with Medical Affairs, Commercial and other functions in these activities as required, consistent with corporate policies, to ensure that broad cross-functional perspectives are incorporated into Clinical Development Plans and protocols as appropriate.
  • Stay abreast of professional information and technology through conferences, medical literature, and other available training, to augment expertise in the therapeutic area.
  • Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. Serves as a clinical representative for key regulatory discussions.
  • Ensure adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research.
Requirements:
  • Medical Doctor (M.D.), Doctor of Osteopathy (D.O.) or non-US equivalent of M.D. degree with relevant therapeutic specialty in an academic or hospital environment. Completion of a residency program strongly preferred. Completion of a subspecialty fellowship is desirable.
  • At least 0-2 years of clinical trial experience in the pharmaceutical industry, academia, or equivalent.
  • Ability to run a clinical research program of moderate complexity with minimal supervision.
  • Ability to perform and bring out the best in others on a cross-functional global team.
  • Ability to interact externally and internally to support a global scientific and business strategy.
  • Knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials and experience in development of clinical strategy and the design of study protocols.
  • Must possess excellent oral and written English communication skills.
Additional Information:

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie's policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html

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